JPRN-jRCT2080223679已完成2 期
A Randomized, Double-blind, Placebo Controlled, 3- Part, Adaptive Design, Multicenter Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH): FLIGHT-FXR
ovartis Pharma K. K.0 个研究点目标入组 350 人开始时间: 2017年10月17日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 350
研究概览
简要总结
Efficacy: In all parts, a dose response of LJN 452 to decreases in ALT and hepatic fat mass was observed. No dose response of LJN 452 was observed for AST reduction. Safety: No significant safety concerns were identified. The incidence of SAEs and events did not appear to be dose dependent. Consistent with the known information for FXR agonists, pruritus was the most frequently reported AE, with incidence and severity increasing with LJN 452 dose, although most subjects were able to continue treatment.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •*male/female patients, 18 years or older
- •*written informed consent
- •*Part A and B patients: presence of NASH by histological evidence (liver biopsy obtained 2 years or less prior to randomization) with fibrosis level of F1, F2 or F3 (fibrosis in the absence of cirrhosis) and no diagnosis of chronic liver disease and elevated alanine aminotransferase (ALT) OR phenotypic diagnosis based on elevated ALT, BMI and diagnosis of Type 2 diabetes mellitus (DM)
- •*Part C patients: presence of NASH by histological evidence (liver biopsy obtained during the Screening period or 6 months or less prior to randomization) with fibrosis level of F2 or F3 and no diagnosis of chronic liver disease
- •And ( All Parts):
- •*ALT >= 43 IU/L (males) or >= 28 IU/L (females)
- •*Liver fat equal to or higher than 10% by MRI
排除标准
- •*previous exposure to OCA
- •*patients taking prohibited medications
- •*patients taking the following medicines UNLESS on a stable dose (within 25% of baseline dose) for at least 1 month before randomization: (for Part C patients, dose must be stable for at least 1 month prior to biopsy through Screening: anti- diabetic medications, insulin, beta-blockers, thiazide diuretics, fibrates, statins, niacin, ezetimibe, vitamin E (if doses > 200 IU/day; doses > 800 IU/day are prohibited), thyroid hormone, psychotropic medications, estrogen or estrogen containing birth control
- •*pregnant or nursing (lactating) women
- •*current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening
- •*uncontrolled diabetes mellitus
- •*new use of GLP-1 agonists such as liraglutide, exenatide, lixisenatide, albiglutide or dulaglutide within 3 months of screening
- •*presence of cirrhosis
- •*hepatic decompensation or severe liver impairment
- •*previous diagnosis of other forms of chronic liver disease
- •*patients with contraindications to MRI imaging
- •Other protocol defined inclusion/exclusion criteria may apply.
研究者
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